E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial (E-COMPARED_CH)
European Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial
研究概览
详细说明
Background
Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.
Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care. The trials will be conducted in 8 European countries.
Objective
To compare the clinical and cost-effectiveness of blended CBT and TAU in secondary care
Methods
In Switzerland, a randomized-controlled trial will be carried out in secondary care, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 12 weeks, 18 weeks, 6 months and 12 months).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bern、瑞士、3014
- Department of Clinical Psychology and Psychotherapy
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Zurich
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Kilchberg、Zurich、瑞士、8802
- Sanatorium Kilchberg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
- Informed Consent
- Having access to a PC and Internet connection
- Having a Smartphone that is compatible with the mobile component of the intervention
- Understanding of the German language spoken and written
Exclusion Criteria
- Current high risk for suicide according to the MINI Interview section C
- Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
- Currently receiving psychological treatment for depression
- Being unable to comprehend the spoken and written language (German)
- Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
- Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Blended CBT
Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.
The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
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Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.
The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
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有源比较器:Treatment as usual
Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system.
The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
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Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system.
The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Patient Health Questionnaire-9 (PHQ-9)
大体时间:18 weeks
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18 weeks
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次要结果测量
结果测量 |
大体时间 |
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Assessment of Quality of Life (AQoL-6D)
大体时间:Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)
大体时间:Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)
大体时间:Baseline, 18 weeks, and 12 months
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Baseline, 18 weeks, and 12 months
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EuroQoL (EQ-5D-5L; Herdman et al., 2011)
大体时间:Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)
大体时间:Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
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Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)
大体时间:12 weeks, and 18 weeks
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12 weeks, and 18 weeks
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System Usability Scale (SUS; Brooke, 1996)
大体时间:12 weeks, and 18 weeks
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12 weeks, and 18 weeks
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Patient Health Questionnaire-9 (PHQ-9)
大体时间:Baseline, 12 weeks, 6 months, and 12 months
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Baseline, 12 weeks, 6 months, and 12 months
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合作者和调查者
调查人员
- 首席研究员:Thomas Berger, PhD、University of Bern
出版物和有用的链接
一般刊物
- van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.
- Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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